Comparison of a Laser Keratome to a Mechanical Microkeratome

Comparison of INTRALASE® to AMADEUS™ Microkeratome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366574

Enrollment

Registered

2006-08-21

Start date

2004-09-30

Completion date

2005-02-28

Last updated

2006-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Myopia, Myopic Astigmatism

Brief summary

The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.

Interventions

DEVICEAmadeus Microkeratome

DEVICEIntraLase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Candidate for bilateral wavefront-guided LASIK * Myopia up to -7.00 D * Astigmatism of 0.00 to -1.50 D

Exclusion criteria

* History of ocular pathology * Previous ocular surgery * Very large pupils (greater than 8mm diameter, infrared measurement) * Thin corneas (preoperatively calculated minimal residual bed \< 250 um) * Irregular astigmatism * Asymmetric astigmatism * Unstable refraction * Any other criteria that precludes subject to undergo LASIK

Design outcomes

Primary

Measure	Time frame
Visual acuity	—
Contrast sensitivity	—
Induction of high order aberration	—
Corneal sensation	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026